The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Interlink System Extension Set With Control-a-flo-regulatory Clearlink System Extension Set With Control-a-flo-regulator.
| Device ID | K121634 |
| 510k Number | K121634 |
| Device Name: | INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORPORATION 25212 W. ILLINOIS ROUTE 120 Round Lake, IL 60073 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORPORATION 25212 W. ILLINOIS ROUTE 120 Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-04 |
| Decision Date | 2012-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412069307 | K121634 | 000 |
| 50085412046391 | K121634 | 000 |
| 50085412004032 | K121634 | 000 |
| 50085412002427 | K121634 | 000 |